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Stevens Johnson Syndrome & Toxic Epidermal Necrolysis (SJS/TEN) Lawsuits FAQ

What is Stevens Johnson Syndrome?

Stevens-Johnson Syndrome (SJS) is essentially an adverse reaction to medication and a debilitating, potentially life-threatening skin disease. Approximately 150,000 deaths per year in the US are caused by adverse drug reactions (ADRs) and SJS is recognized as one of the most serious ADRs. SJS affects the skin and mucous membranes and typically causes severe burning and blistering and sloughing of affected tissue. In severe cases (usually when it progresses to TENS) SJS can cause blindness and even death. It was first discovered by pediatricians in 1922, after a child was diagnosed with severe ocular and oral reaction to a drug.

What is TENS?

TENS (Toxic Epidermal Necrolysis Syndrome) is a more severe form of SJS. Both SJS and TEN are life-threatening reactions but the mortality rates are about 5 percent with SJS, and 30-35 percent with TENS. With TENS the skin also begins to peel away in large amounts, similar to severe burning. Fluids can seep in these areas and infection is a major risk.

What Causes SJS?

Stevens-Johnson Syndrome is mainly drug-induced, i.e. through an allergic drug reaction, although a few cases are caused by bacterial infections and skin graft problems. A few other cases remain unexplained. Infections that can cause Stevens-Johnson syndrome include:

• Herpes (herpes simplex or herpes zoster)
• Influenza
• HIV
• Diphtheria
• Typhoid
• Hepatitis

Which drugs cause SJS?

Almost any medication can cause SJS, including over-the-counter drugs (OTC), such as Advil (Ibuprofen) which are used to treat seizures, and Children's Motrin which are used to treat seizures.

The drugs most commonly responsible are:

• NSAIDS (non-steroidal anti-inflammatory drugs),
• Antibiotics used to treat infections (such as sulfa, penicillin and cephalosporin)
• Anti­-inflammatory medications (such as Bextra)
• Anti-gout medications, such as allopurinol
• Anticonvulsants, such as Dilantin which are used to treat seizures

Due to an increase in SJS cases, in May 2006, the FDA requested that several over-the-counter (OTC) and prescription medication have warning labels. The following medications had additional wording or a new warning with regards to SJS: 

• Tolectin 600 Tablets (Tometin Sodium)
• Tolectin DS Capsules (Tometin Sodium)
• Advil Allergy Sinus Tablets (200 mg ibuprofen / 30 mg pseudoephedrine HCI / 2 mg chlorpheniramine maleate)
• Advil Cold & Sinus Tablets (200 mg ibuprofen / 30 mg pseudoephedrine HCI)
• Motrin IB Tablets (200 mg ibuprofen)
• Children's Motrin Chewable Tablets (50 mg ibuprofen)
• Motrin Junior Strength Chewable Tablets (100 mg ibuprofen)
• Motrin Infants' Drops (50 mg / 1.25 mL ibuprofen oral suspension)
• Advil Liqui-Gels (200 mg ibuprofen capsules)
• Motrin Cold & Sinus Tablets (200 mg ibuprofen / 30 mg pseudoephedrine HCI)
• Advil Migraine Capsules (200 mg ibuprofen)

Are there any warning signs or symptoms of SJS?

The onset of SJS symptoms caused by a drug reaction may not appear for one or two weeks after first taking the drug.

Recognition of early warning signs and immediate medical attention can reduce the possible long-term effects SJS may have on its victims. Understanding the cause of SJS (i.e. allergic reaction to a drug, including over-the-counter drugs) can also minimize further harm—by discontinuing the harmful medication(s).

It is important to note that some health professionals are still not aware of early SJS symptoms. LawyersandSettlements has interviewed a number of victims who were first diagnosed with flu and sent home, only to return to the emergency ward with SJS/TENS.

According to the Mayo Clinic, warning signs include:

• Rash, blisters, or red splotches on skin
• Persistent fever
• Blisters in mouth, eyes, ears, nose, genital area
• Swelling of eyelids, red eyes
• Conjunctivitis
• Flu-like symptoms
• Recent history of having taken a prescription or over-the-counter medication. Target lesions are not always seen in SJS!

As well, a SJS victim can first experience non-specific symptoms, such as headaches, aching body, fever, and a bad cough, followed by a rash that usually begins over the face and torso then spreads to other parts of the body. Next, blistering can occur, usually in places such as the eyes, mouth, nose and genital areas, and the mucous membrane becomes inflamed.

Can I get SJS/TEN?

Anyone can develop SJS although most victims are children—mainly due to medications such as Children's Motrin, Advil and Ibuprofen-based drugs. And more female cases have been reported than male. The SJS Foundation has reports from people worldwide who suffer from SJS and TENS. Unfortunately, there is no way to predict who will get SJS after taking a new medication, but some factors may increase your risk of developing Stevens-Johnson syndrome:

• Existing medical conditions. Viral infections, diseases that decrease your immunity, human immunodeficiency virus (HIV) and systemic lupus erythematosus — a chronic inflammatory disease — increase your risk of developing Stevens-Johnson syndrome.
• Genetics. Carrying a gene called HLA-B12 may make you more susceptible to Stevens-Johnson syndrome.

What is the prognosis for SJS?

If left untreated, SJS/TENS can cause death. Reported complications and symptoms can include permanent blindness, dry-eye syndrome, photophobia, lung damage, chronic obstructive pulmonary disease (COPD), asthma, permanent loss of nail beds, scarring of the esophagus and other mucous membranes, arthritis, and chronic fatigue syndrome.

What is the treatment for SJS?

Early treatment is crucial in the management of SJS patients, particularly the recognition and withdrawal of all potential causative drugs. Intravenous fluid replacement must be initiated using macromolecules or saline solutions and the patient must be transferred to an intensive care unit or a burn center.

The main types of treatment are similar to that of burn victims, however, TEN and burned patients are not identical: burns happen in a very short time period (a few seconds) and do not spread thereafter; the TEN-SJS progress occurs during several days, including after hospital admittance.

It is important that anyone diagnosed with SJS is treated in a sterile environment, because this disease can leave victims open to secondary infections. If you have already contracted an infection on top of the SJS, your doctor may also need to administer antibiotics. Depending upon your health and the severity of the disease, you may need fluid replacement and topical steroids, and your doctor may also have to administer oral and eye exams and treatments.

How can I prevent SJS/TENS from recurring?

SJS/TENS survivors should not be re-exposed to the suspected drug or related compound(s). For example, cross-reactions have been reported between different anticonvulsant agents or non-steroidal anti-inflammatory drugs, such as the oxicams. As well, genetic factors are suspected in drug-induced blistering disorders, so any suspected drug should not be used in the blood relatives of the patient.

Can I file a lawsuit if I developed SJS or SJS/TENS from a drug reaction?

Many lawsuits for SJS are being filed against companies such as Pfizer, G. D. Searle, Pharmacia, McNeil, and Johnson & Johnson for drugs such as Children's Motrin, Daypro, and Bextra.

In April 2005, the FDA asked Pfizer, the manufacturer of Bextra, to remove Bextra from the market. In October 2008, Pfizer reached an $894 million deal to settle most lawsuits over its withdrawn pain reliever Bextra.

A jury in Pasadena, California awarded over $6 million to an 82 year-old Chinese female immigrant who suffered SJS/TENS after being prescribed Allopurinol for allegedly having gout. The woman reportedly maintained that she did not have gout but took the drug anyway which resulted in her developing SJS.

On June 2, 2004, nine-year-old Jerra died of TEN. She had suffered seizures and Dilantin was prescribed. She was also given Flagyl and Children's Motrin. In May 2006 her parents filed a wrongful death suit against G.D. Searle & Co., Pharmacia Corp., Pharmacia & Upjohn Company, Pfizer (collectively, the Pfizer defendants), and McNeil Consumer & Specialty Pharmaceuticals.

In September 2010 a woman was awarded $21 million in a lawsuit against Mutual Pharmaceutical Co., the maker of Sulindac, the generic version of Clinoril. The lawsuit alleged that Sulindac has the highest number of reported incidents of SJS/ TEN of any non-steroidal anti-inflammatory drug available on the market. The lawsuit claimed that the drug should not have been on the market.

Drug manufacturers are obligated to notify physicians and patients of any potential harmful adverse health events and side effects of drugs. Failure to do so often makes them financially liable for any adverse effects suffered by patients who have taken their drugs. If you or your loved one suffered SJS due to an allergic drug reaction, an experienced personal injury attorney can help determine if compensation is available.